Pneumococcal Infection Clinical Trial
Official title:
Single-blind, Single-center, Randomized, Active-controlled, Parallel Group, Phase I Study to Evaluate the Safety and Immunogenicity of Intramuscular Single Injection With Pneumococcal Conjugate Vaccine or Prevnar13 in Healthy Adults
Verified date | May 2018 |
Source | LG Chem |
Contact | Soie Park |
Phone | 02-6987-4160 |
soiep[@]lgchem.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
phase-1 study pneumococcal conjugate vaccine study in healthy adults
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | July 25, 2019 |
Est. primary completion date | April 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Healthy adult older than 19 years old and younger than 50 years old - A subject who was informed of the purpose, method, and efficacy of the clinical study and signed the written informed consent form Exclusion Criteria: - A subject who participated in other clinical studies within 3 months before screening - A subject who was vaccinated with other vaccines within 4 weeks before screening, or who is expected to receive other vaccination during the clinical study period - A subject with medical history of hypersensitive reactions (e.g. anaphylaxis) to the test drug or its ingredients - A subject who received immunoglobulin or blood-derived materials within 3 months before screening - A subject with immunologic function disorders including congenital or acquired immunodeficiency disorders - A subject who is receiving immunosuppressive therapy or drugs that can affect immunological reaction - A subject with pyrexia of over 38 Celsius degrees on the day of the vaccination with the investigational products - A subject with medical history of Invasive Pneumococcal Disease (IPD) or pneumonia caused by Streptococcus pneumoniae - A subject who was vaccinated with any pneumococcal vaccine before screening - A subject who received the vaccine containing diphtheria toxoid within 6 months before screening (e.g. adult Td vaccine) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
LG Chem |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Solicited adverse events | Solicited adverse events | Baseline(pre-vaccination) up to 7 days after | |
Primary | Unsolicited adverse events | Unsolicited adverse events | Baseline(pre-vaccination) up to 4 weeks after vaccination | |
Primary | Immediate reactions after vaccination | Immediate reactions after vaccination | Baseline(pre-vaccination) up to 30 minutes after vaccination | |
Secondary | Serotype-Specific Pneumococcal immunoglobulin G antibody Geometric Mean Concentrations (GMCs) 4 weeks After Vaccination | GMC | 4 weeks After Vaccination | |
Secondary | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 4 weeks After Vaccination | GMT | 4 weeks After Vaccination | |
Secondary | Proportion of subjects achieving 4-fold rise in Pneumococcal Opsonophagocytic Activity (OPA) titer at 4 weeks after vaccination | OPA titer | 4 weeks after vaccination |
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